There is much excitement surrounding the advent of immune checkpoint inhibitors, says Grivas. Many of the approvals in urothelial cancer were based on single-arm phase II trials. There have been 2 randomized phase III trials trying to evaluate the role of immune checkpoint inhibitors, such as pembrolizumab (Keytruda) versus single-agent taxane—docetaxel or paclitaxel—in the United States.

The trial met the primary endpoint of overall survival (OS) benefit with pembrolizumab as a salvage therapy versus chemotherapy in patients with platinum-refractory advanced urothelial cancer, says Grivas. The median OS difference was about 3 months, favoring pembrolizumab in all-comers.

Based on the assay that was used, patients with higher PD-L1 expression still showed benefit with pembrolizumab. This provided level 1 evidence for the use of pembrolizumab in patients with platinum-refractory advanced urothelial cancer. That agent has the highest level of evidence in the salvage setting in patients who progress on or after platinum-based chemotherapy, Grivas says.

There is much excitement surrounding the advent of immune checkpoint inhibitors, says Grivas. Many of the approvals in urothelial cancer were based on single-arm phase II trials. There have been 2 randomized phase III trials trying to evaluate the role of immune checkpoint inhibitors, such as pembrolizumab (Keytruda) versus single-agent taxane—docetaxel or paclitaxel—in the United States.

The trial met the primary endpoint of overall survival (OS) benefit with pembrolizumab as a salvage therapy versus chemotherapy in patients with platinum-refractory advanced urothelial cancer, says Grivas. The median OS difference was about 3 months, favoring pembrolizumab in all-comers.

Based on the assay that was used, patients with higher PD-L1 expression still showed benefit with pembrolizumab. This provided level 1 evidence for the use of pembrolizumab in patients with platinum-refractory advanced urothelial cancer. That agent has the highest level of evidence in the salvage setting in patients who progress on or after platinum-based chemotherapy, Grivas says.